Senior Supervisor- Quality Engineering

Work location North Tonawanda, NY; Trumbull, CT; or Livingston, NJ (on‑site) Scope The Product Surveillance Sr. Supervisor is responsible for providing strategic oversight and leadership of post‑market surveillance and product complaint investigation activities for combination drug‑device products in compliance with applicable U.S. and international regulatory requirements, including 21 CFR Parts 210, 211, 820, and ISO 13485. This role ensures the consistent, compliant, and scientifically sound execution of risk‑based complaint investigations through effective application of investigation methodologies, root cause analysis, and risk assessment principles, and has accountability for investigation quality, prioritization, escalation decisions, and inspection readiness, while driving cross‑functional alignment and continuous improvement of the Product Surveillance function in support of product safety, regulatory compliance, and patient protection. Job Summary The Product Surveillance Sr. Supervisor oversees and directs comprehensive, risk‑based product complaint investigations for combination drug‑device products, ensuring timely, thorough, and compliant evaluation of post‑market information. This position is responsible for the intake, review, triage, assignment, and approval of complaint investigations, as well as evaluating investigation outcomes to determine appropriate escalation actions, including CAPA initiation, Health Hazard Evaluations, trend analysis, regulatory reporting, and field actions such as recalls or field alerts. This role leads cross‑functional collaboration with Quality, Regulatory Affairs, R&D, Manufacturing, Medical Affairs, Supply Chain, and external partners to drive effective complaint resolution, post‑market risk evaluation, and data alignment, and oversee verification of investigation conclusions and corrective actions, ensuring the integrity and traceability of complaint and post‑market surveillance records, and maintain audit‑ready documentation, and will also coach and mentor Product Surveillance personnel, promote consistent investigative practices, and serve as a subject‑matter expert during internal and external audits and inspections, develop and present routine post‑market surveillance metrics and trending analysis to leadership and drive continuous improvement of post‑market surveillance and Quality Management System processes based on investigation outcomes, risk signals, and evolving regulatory expectations. #J-18808-Ljbffr CooperCompanies